Manufacturing Support Engineer

The Manufacturing Support Engineer serves as the primary equipment, facility, and utility (EFU) technical resource for manufacturing operations, providing real-time on-the-floor support for production activities. This role is responsible for supporting unit operation setup, responding to operator questions, troubleshooting EFU issues, and ensuring safe, efficient, and uninterrupted manufacturing operations. This is a full-time on-the-floor support position.

The position works directly with operators, manufacturing management, maintenance, quality, validation, MS&T, and engineering teams to resolve technical issues, minimize downtime, and maintain compliance with GMP requirements. The successful candidate will act as a Subject Matter Expert (SME) for manufacturing EFU, providing immediate support to production while driving operational reliability and continuous improvement.

• Provide daily on-the-floor technical support for manufacturing operations across all assigned unit operations.
• Support setup, startup, operation, and shutdown of production equipment and manufacturing processes.
• Serve as the first point of contact for operators regarding equipment and technical issues during manufacturing activities.
• Monitor manufacturing performance and identify potential issues before they impact production.
• Actively participate in daily before-shift and after-shift hand-off reviews with MFG and outgoing/incoming Manufacturing Support Engineer.

• Lead real-time troubleshooting EFU issues to minimize production downtime.
• Support process SMEs in real-time troubleshooting of process-related issues.
• Investigate mechanical, process, automation, and operational problems impacting manufacturing activities.
• Analyze process and equipment data to identify root causes and implement effective corrective actions.
• Partner with Maintenance, Facilities, Automation, and Engineering teams to resolve recurring equipment and operational issues.
• Provide technical assessments and recommendations to improve equipment reliability and operational performance

• Act as the SME for assigned manufacturing systems, single-use technologies, and unit operations.
• Assist with consumable and raw material integration to ensure compatibility with manufacturing processes and equipment.
• Evaluate equipment and process performance trends and recommend improvements to increase efficiency and reliability.
• Support manufacturing readiness activities to ensure production equipment and systems are prepared for execution.

• Review and support manufacturing EFU documentation including batch records, SOPs, work instructions, and technical reports.
• Provide technical input for deviations, investigations, change controls, CAPAs, and risk assessments.
• Support root cause analysis activities and assist in identifying sustainable corrective and preventive actions.
• Ensure technical documentation accurately reflects manufacturing practices and regulatory requirements.
• Support data gathering, analysis, and documentation associated with production events and investigations.

• Work closely with Manufacturing, Quality Assurance, Quality Control, MS&T, Validation, Facilities, and Supply Chain to resolve production-related issues.
• Communicate technical findings, operational concerns, and recommended actions to stakeholders in a clear and timely manner.
• Participate in production meetings and provide technical updates related to ongoing manufacturing activities.
• Support successful execution of GMP manufacturing campaigns through proactive technical engagement.

• Provide technical guidance and coaching to operators, manufacturing personnel, and other Engineering and support staff.
• Support training initiatives related to equipment operation, troubleshooting, and process execution.
• Share lessons learned and best practices to improve operational knowledge across manufacturing teams.
• Serve as a technical resource during EFU-related manufacturing investigations and operational reviews.

• Bachelor's degree in Engineering, Biotechnology, Chemical Engineering, Mechanical Engineering, Industrial Engineering, or related technical discipline.
• 5+ years of experience supporting cell culture, purification, mRNA, or other biologics manufacturing processes.
• Demonstrated experience troubleshooting manufacturing equipment, process systems, or…